Long Term Post Marketing Specified Drug Use Result Survey for Evolocumab in Japan (20140409) (Evolocumab Long term PMS Japan)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  REPATHA
• Study drug International non-proprietary name (INN) or common name:
  EVOLOCUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (C10AX13) evolocumab

  evolocumab
• Medical condition to be studied:
  Hypercholesterolaemia
• Additional medical condition(s):
  Familial hypercholesterolemia (heterozygous or homozygous)

Population studied

• Short description of the study population:
  Patients for whom evolocumab is prescribed at participating medical institutions in accordance with the approved Japan prescribing information.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Renal impaired
• Estimated number of subjects:
  6000

Study design details

• Main study objective:
  To determine the incidence of adverse events and adverse drug reactions (adverse events for which causal relation to evolocumab cannot be ruled out) among patients receiving evolocumab for up to 2 years, and to identify and describe patient characteristics associated with the safety and effectiveness of evolocumab therapy.
• Outcomes:
  Incidence (%), number of patients and number of events per 1,000 person-years with adverse drug reactions and serious adverse events during the observational period (up to 2 years), and Percent change in LDL-C from baseline to Week 12, ; Incidence (%), number of patients and number of events per 1,000 person-years with adverse drug reactions and serious adverse events in sub-population of patient characteristics, including the patient sub-populations specified as important missing information
• Data analysis plan:
  A descriptive analysis is conducted. Categorical variables are summarized with frequencies and percentage. Continuous variables are summarized with mean, standard deviation (SD), median, 1st Quartile (Q), and 3rd Q.When statistical testing and inference are applied, two-sided p-value of <0.05 is considered significant and the 95% confidence interval (CI) is estimated. Adjustment for multiple comparisons is not considered.

Documents

Study report

20140409 ORSR abstract.pdf